HD Blog

Amarin Announces Commencement Of Recruitment By Huntington Study Group For Miraxion Phase III Clinical Trial

LONDON, United Kingdom, June 14th, 2005 – Amarin Corporation plc (NASDAQSC: AMRN) today announced that the Huntington Study Group ("HSG") has commenced recruitment for the U.S. Phase III clinical trial of MiraxionTM in Huntington's disease.

The HSG will be conducting a clinical study (TREND-HD) of ultra-pure ethyl-EPA in persons 35 years of age or older who have mild to moderate Huntington's disease. The HSG is a worldwide, not-for-profit group of physicians and other clinical researchers who are experienced in the care of Huntington's disease patients and dedicated to clinical research in Huntington's disease.

Huntington's disease is an inherited disease of the brain that usually begins between the ages of 30 to 50, and includes motor, cognitive and behavioral signs and symptoms. While there are medications to help relieve some of the disease symptoms, there is no known treatment to slow the progression of Huntington's disease, which affects about 30,000 people in North America.

Miraxion is thought to stabilize nerve cell membranes and improve neurological functioning, although the exact mechanism of action is not currently known. An earlier trial in subjects with Huntington's disease indicated that Miraxion at 2 grams daily was well tolerated over 12 months. This current trial is designed to determine the effect of this daily dose of Miraxion on motor (movement) signs and symptoms of Huntington's disease.

The current 12 month study includes a 6 month placebo controlled phase with research subjects being randomly assigned to receive either Miraxion (2 grams total daily dose) or a matching placebo. This will be followed by another 6 month observation phase in which all participants will receive Miraxion. Researchers at 43 sites in the United States and Canada will each enroll approximately 7-8 research subjects with early signs of Huntington's disease who are independently ambulatory (walking) and fully self sufficient in activities of daily living, such as eating, dressing and bathing.

There is no cost to participate in the study. Participants will be followed as "out-patients" at regular intervals for 12 months. Individuals with mild to moderate Huntington's disease who are interested in participating in this study should visit the Huntington's Study Group website at: www.Huntington-Study-Group.org or call the toll free number +1 (800) 487 7671.

Rick Stewart, chief executive officer of Amarin, commented; "commencement of recruitment to the Phase III clinical trial for Miraxion is a major milestone for Amarin. An immense amount of energy and dedication has been expended by all involved to achieve this significant objective."